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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01603-38 | Registry Identifier | ANSM |
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| Name | Class |
|---|---|
| ANRS, Emerging Infectious Diseases | OTHER_GOV |
| Gilead Sciences | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
| Mairie de Paris |
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With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.
In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.
The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELISA testing | Active Comparator | HBV infection status determined by enzyme-linked immuno-assay (ELISA) |
|
| Rapid testing | Experimental | HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISA testing | Other | Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Appropriately Seeking Care | Subjects who are considered required to seek further care are as follows:
Of these patients, subjects who have achieved appropriate care are considered as follows:
The percentage of patients appropriately seeking care will be then calculated by the following formula: ((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Bottero, MD | Hôpital Saint-Antoine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Santé au Maire-Volta | Paris | 75003 | France | |||
| Centre d'examen de santé de la CPAM, antenne rue du Maroc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26954517 | Result | Bottero J, Boyd A, Gozlan J, Carrat F, Lemoine M, Rougier H, Varsat B, Boo N, Charlois-Ou C, Collignon A, Cha O, Campa P, Dhotte P, Girard PM, Lacombe K. Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study. Eur J Gastroenterol Hepatol. 2016 Jun;28(6):633-9. doi: 10.1097/MEG.0000000000000620. |
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Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.
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2061 participants were initially screened for eligibility. Of them, 625 did not meet inclusion criteria and 436 declined to participate. In total, 1000 participants were randomized.
From 29 February 2012 to 5 July 2012, volunteers were recruited from five study centers in the Paris metropolitan region, which actively participate in HBV screening, vaccination, and care - two sexually transmitted disease clinics, one primary healthcare center, one general screening center, and one travel clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | ELISA Testing | HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). |
| FG001 | Rapid Testing | HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants completing their intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | ELISA Testing | HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Appropriately Seeking Care | Subjects who are considered required to seek further care are as follows:
Of these patients, subjects who have achieved appropriate care are considered as follows:
The percentage of patients appropriately seeking care will be then calculated by the following formula: ((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100 | Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive). | Posted | Number | percentage of participants | 6 months |
|
6 months
Any event possibly related to physical HBV test.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ELISA Testing | HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). |
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Low prevalence of HBV infection; individuals with barriers to healthcare were underrepresented; Quick Profile anti-HBsAb rapid test unable to confirm nonimmunized status; intervention had same-day blood draws, which is not done in routine practice.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Bottero | Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine | +33 1 49 28 04 24 | julie.bottero@aphp.fr |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| UNKNOWN |
| BioMérieux | INDUSTRY |
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| Rapid testing | Other | A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day. |
|
|
| Paris |
| 75012 |
| France |
| Consultation Policlinique de l'hôpital Saint-Antoine | Paris | 75012 | France |
| Consultation Voyage de l'hôpital Saint-Antoine | Paris | 75012 | France |
| CDAG de Belleville | Paris | 75020 | France |
| Rapid Testing |
HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| HBV prevalence of birth country | Number | participants |
|
| Health insurance plan | Number | participants |
|
| ELISA Testing |
HBV infection status determined by enzyme-linked immuno-assay (ELISA) ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). |
| OG001 | Rapid Testing | HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day. |
|
|
|
| 0 |
| 496 |
| 0 |
| 496 |
| EG001 | Rapid Testing | HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days). Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day. | 0 | 499 | 0 | 499 |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |